Regulatory Research Coordinator I

Erlanger Health System•Chattanooga, TN

About The Position

This role is responsible for preparing, completing, and submitting required forms and documents, in consultation with the research team, to meet regulatory, IRB, and HIPAA guidelines and policies, at the time of initial review, modifications, and continuing review. The Research Regulatory Coordinator II has a direct line of communication and working relationship with external investigators and/or research teams. Performs informed consent review and modifies consent form/HIPAA language while working with sponsors and IRBs for all studies to conform to institutional guidelines. During times of staff shortage must be able to cross cover for Research Coordinator II positions as needed for patient enrollments and care.

Requirements

Associates Degree and/or 2 - 3 year's equivalent work experience in clinical research or other related field.
2 - 3 year's prior experience in a research medical office or academic hospital setting or other related field.
Knowledge of personal computing with word processing, spreadsheets and database management.
Basic understanding of medical terminology.
Self-motivated, professional and accountable.
Detail oriented with ability to handle multiple tasks/projects simultaneously.
Must be able to plan, prioritize and complete tasks under stress with frequent interruptions.
Familiarity with the Code of Federal Regulations as they pertain to human subject clinical research.
Strong interpersonal skills.
Understanding of clinical research process.
Highly motivated with the ability to take initiative in supporting the research department.
Clinical Research Certification (SoCRA, CCRP or ACRP) or be able to obtain within 2 years from hire date.
Certification in Institution Review Board required Course in The Protection of Human Research Subjects (CITI) course, Conflict of Interest and Good Clinical Practice.
International Air Transportation Association (IATA) certification for shipping dangerous goods and biological substances (if not current at hire date, must be completed within the first 3 months of employment).
Current Driver's License.
Understanding of all federal and local agencies including (but not limited to) the Food and Drug Administration (FDA) and local Institutional Review Board (IRB) as well as the Central Institutional Review Board (CIRB) with ability to work within all guidelines set forth.
Must be a professional, multi-skilled person dedicated to assisting in all aspects of research practice.

Nice To Haves

Graduate from an accredited School of Nursing.
Two years or more of research regulatory experience strongly recommended.
Knowledge and understanding of application of approved clinical practices.
Experience with research and/or grants and in health care system.
Phlebotomy training and/or experience.
Clinincal Research experience.
Experience in regulatory affairs in industry.
Research certification with Prim&r or RAC.

Responsibilities

Preparing, completing, and submitting required forms and documents to meet regulatory, IRB, and HIPAA guidelines and policies.
Consulting with the research team on regulatory submissions.
Communicating and working with external investigators and/or research teams.
Performing informed consent review and modifying consent form/HIPAA language.
Working with sponsors and IRBs to conform studies to institutional guidelines.
Cross-covering for Research Coordinator II positions for patient enrollments and care during staff shortages.
Assisting senior regulatory and/or research coordinator with review of case report forms, informed consents, and other study-related material.
Assisting with maintaining monthly billing for study visits and documenting appropriate fees on research referral forms.
Assisting with the collection of data from patient charts, medical records, interviews, questionnaires, and other sources.
Organizing and facilitating meetings, conferences, and other events associated with research activities.
Coordinating outreach activities as appropriate for research objectives.
Submitting research-related contracts and supporting documents to the IRB Administrator.
Tracking the progress of research contracts through the system and providing weekly updates to management.
Updating a department-wide Microsoft Outlook calendar with appointments, meetings, vacations, and other departmental events.
Assisting with developing and maintaining up-to-date departmental policies and procedures.
Assisting with the maintenance of departmental information, including faculty CVs, current licensures, lab certifications, lab normal and abnormal values, staff training certifications, and protocol-specific requirements.
Working with Marketing to ensure currently enrolling studies are updated on the EHS website.
Performing special projects as assigned.
Maintaining research practices using Good Clinical Practice (GCP) guidelines.
Maintaining strict patient confidentiality according to HIPAA regulations and applicable law.
Preparing, completing, and submitting required forms and documents under the direction of the Senior Regulatory or Senior Research Coordinator.